NeuroRegen Scaffold™ With Stem Cells for Chronic Spinal Cord Injury Repair

NCT02352077 | Unknown Phase 1

• 1 other identifier: CAS-XDA-SCI/IGDB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the safety and efficacy of NeuroRegen scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) in patients with chronic spinal cord injury.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation Number of patients with adverse events

  Number of patients with adverse events is as a measure of safety and tolerability after collagen scaffold with MSCs transplantation.

  6 months

Secondary Outcomes (6)

• Improvements in Neurophysiological Measures omatosensory Evoked Potentials (SSEP) and Motor Evoked Potentials (MEP) monitoring will be assessed

  12 months

• Improvements in ASIA Impairment Scale

  12 months

• Improvements in Independence Measures and Quality of Life

  12 months

• Improvements in Pain assessed based on Visual analog scale (VAS)

  12 months

• Improvements in Urinary and Bowel Function assessed based on bladder pressure monitory before and after transplantation

  12 months

Study Arms (1)

NeuroRegen Scaffold with BMMCs or MSCs transplantation

EXPERIMENTAL

Biological: NeuroRegen scaffold with BMMCs or MSCs transplantation

Interventions

NeuroRegen scaffold with BMMCs or MSCs transplantation BIOLOGICAL

Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.

NeuroRegen Scaffold with BMMCs or MSCs transplantation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years old.
• Completely spinal cord injury at the cervical and thoracic level (C5-T12).
• Classification ASIA A with no significant further improvement.
• Patients signed informed consent.
• Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.

You may not qualify if:

• A current diagnosis of any primary diseases affecting limb functions (e.g., trauma, infection, tumors, congenital malformations, peripheral muscular dystrophy, Huntington's disease, Parkinson's disease).
• Serious complications (e.g., hydronephrosis due to renal insufficiency, severe bedsores (Ⅲ° above), lower extremity venous thrombosis, severe myositis ossificans).
• History of life threatening allergic or immune-mediated reaction.
• Clinically significant abnormalities in routine laboratory examinations (hematology, electrolytes, biochemistry, liver and kidney function tests, urinanalysis).
• History of mental illness or suicide risk, with a history of epilepsy or other central nervous system disorders.
• Severe arrhythmias (e.g., ventricular tachycardia, frequent superventricular tachycardia, atrial fibrillation, and atrial flutter) or cardiac degree II or above conduction abnormalities displayed via 12-lead ECG.
• Lactating and pregnant woman.
• Alcohol drug abuse /dependence.
• Participated in any other clinical trials within 3 months before the enrollment.
• A drug or treatment known to cause effect on the central nervous system during the past four weeks.
• A drug or treatment known to cause major organ system toxicity during the past four weeks.
• Poor compliance, difficult to complete the study.
• Any other conditions that might increase the risk of subjects or interfere with the clinical trial.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Affiliated Hospital of Logistics University of CAPF: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• First Hospitals affiliated to the China PLA General Hospital: collaborator

Study Sites (3)

First Hospitals affiliated to the China PLA General Hospital

Beijing, 100037, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Affiliated Hospital of Logistics Universtiy of CAPF

Tianjin, 300162, China

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jianwu Dai, Ph.D

  Chinese Academy of Sciences

  PRINCIPAL INVESTIGATOR

• Sai Zhang, M.D

  Affiliated Hospital of Logistics Universtiy of CAPF

  STUDY CHAIR

• Huilin Yang, Ph.D

  The First Affiliated Hospital of Soochow University

  STUDY CHAIR

• Shuxun Hou

  First Hospitals affiliated to the China PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 23, 2020

Record last verified: 2016-10

Locations

CN (3)